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Von Willebrand Disease (VWD)Phase 3NCT07129343

A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)

A Phase 3 study testing VONVENDI and ADVATE in people with Von Willebrand Disease (VWD), run by Takeda at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main aim of this study is to find out if VONVENDI is safe for adult Chinese participants with VWD. The study will also check how well VONVENDI helps control bleeding with or without product ADVATE in the participants who may need elective surgery or dental procedures. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Von Willebrand Disease (VWD)
What is being tested?
VONVENDI and ADVATE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
7 sitesChina
Study dates
13 Oct 2025to 25 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must voluntarily sign an institutional review board (IRB)/independent ethics committee-approved written informed consent form after all relevant aspects of the study have been explained and discussed with the participant.
  • Participant has a documented diagnosis of severe VWD (baseline VWF:RCo less than [<]20 international units [IU]deciliter [dL]) with a diagnosis of VWD type verified per the following recommended criteria:
  • Type 1 (von Willebrand factor:Ristocetin cofactor activity [VWF:RCo] <20 IU/dL and by VWF activity/VWF:antigen [Ag] ratio) or,
  • Type 2A or type 2B (by VWF activity/VWF:Ag ratio and multimer pattern, with genetics if necessary), type 2N (FVIII:C <10% and genetics), type 2M (by VWF activity/VWF:Ag ratio and multimer pattern) or
  • Type 3 (VWF:Ag <=3 IU/dL). Diagnosis is confirmed, when applicable, by genetic testing and/or by multimer analysis.
  • Participant is at least 18 years of age at screening.
Show all 10Show fewer
  • Participant is ethnic Chinese and lives in China, including those from Taiwan, Hong Kong, and Macao.
  • If female of childbearing potential, participant presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
  • Participant is willing and able to comply with the requirements of the protocol.
  • Participant has had a minimum of 3 documented bleeds that indicated the need for VWF coagulation factor replacement therapies during the previous 12 months prior to enrollment.

Who cannot join

  • Participant has been diagnosed with pseudo VWD or another hereditary or acquired coagulation disorder other than VWD (example [eg], qualitative and quantitative platelet disorders or elevated prothrombin time [PT]/international normalized ratio >1.4).
  • Participant has a history or presence of a VWF inhibitor at screening.
  • Participant has a documented history of a VWF:RCo half-life of <6 hours.
  • Participant has a history or presence of a FVIII inhibitor with a titer greater than or equal to [>=] 0.6 Bethesda units per milliliter [BU/mL] (by Bethesda assay or Bethesda method with Nijmegen modification).
  • Participant has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins.
  • Participant has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
Show all 20Show fewer
  • Participant has a medical history of a thromboembolic event.
  • Participant is human immunodeficiency virus (HIV) positive with an absolute cluster of differentiation 4 (CD4) count <200/cubic millimeter (mm^3).
  • Participant has been treated with an immunomodulatory drug, other than antiretroviral chemotherapy eg, α-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 milligram (mg)/day (excluding topical treatment [eg, ointments, nasal sprays]), within 30 days prior to signing the informed consent (or assent, if appropriate).
  • Participant is pregnant or lactating at the time informed consent is obtained.
  • Participant has participated in another clinical study involving an IP, or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
  • Participant is diagnosed with progressive fatal disease and/or has a life expectancy of less than 15 months.
  • Participant is member of the study team conducting this study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (that is, children, partner/spouse, siblings, parents) as well as employees.
  • Participant has an acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, nonseasonal asthma) at screening.
  • Participant is diagnosed with significant liver disease, as evidenced by, but not limited to, any of the following: serum alanine aminotransferase (ALT) greater than 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices) or liver cirrhosis classified as Child-Pugh class B or C.
  • Participant has been diagnosed with renal disease, with a serum creatinine level >=2.5 milligram per deciliter (mg/dL).
  • Participant has a platelet count <100,000/ milliliter (mL) at screening (except for participants with type 2B VWD, whose platelet count[s] at screening will be evaluated taking into consideration historical trends in platelet counts and the investigator's medical assessment of the participant's condition).
  • Participant has cervical or uterine conditions causing menorrhagia or metrorrhagia (including infection, dysplasia).
  • In the judgment of the investigator, the participant has another clinically significant concomitant condition (eg, uncontrolled hypertension) that may pose additional risks for the participant.
  • Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100006

    Site Contact, +8618611743292, zhutn@pumch.cn

    Tienan Zhu

    Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, 510515

    Site Contact, +8613316202696, jsun-cn@qq.com

    Jing Sun

    Recruiting

  • Jinan Central Hospital

    Jihan, 250013

    Site Contact, +8613370582720, chyun008@163.com

    Yun Chen

    Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 201801

    Site Contact, +8613641653074, wxf63@shsmu.edu.cn

    Xuefeng Wang

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215005

    Site Contact, +8613913518032, yuziqiang@suda.edu.cn

    Ziqiang Yu

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, 300052

    Site Contact, +8613920673951, xuefeng@ihcams.ac.cn,

    Feng Xue

    Recruiting

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430032

    Site Contact, +8613237100810, lidengju@tjh.tjmu.edu.cn

    Dengju Li

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in the Treatment of Bleeding Episodes in Chinese Subjects Diagnosed With Von Willebrand Disease

The main aim of this study is to find out if VONVENDI is safe for adult Chinese participants with VWD. The study will also check how well VONVENDI helps control bleeding with or without product ADVATE in the participants who may need elective surgery or dental procedures. In addition, the study will also examine how VONVENDI is processed by the body (known as pharmacokinetic [PK]) and how the drug helps the body respond or improve a condition (pharmacodynamic [PD]).

Participants will receive an initial dose of VONVENDI of 40 to 80 international units per kilogram (IU/kg) of body weight. If a participant's baseline factor VIII (FVIII) level is not high enough to help stop bleeding, VONVENDI will be given along with 30 to 45 IU/kg of ADVATE rFVIII.

Participants will be in the study for approximately 14 months. During the study, participants will be followed up at clinics or over telephone calls.

Being tested
VONVENDI, ADVATE
Keywords
Drug Therapy
Medical subject headings
von Willebrand Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VONVENDIBiological

    Also called vonicog alfa, TAK-577, rVWF

    VONVENDI is administered by intravenous injection.

  • ADVATEBiological

    Also called rFVIII, Octocog alfa

    ADVATE is administered by intravenous injection.

Study groups in NCT07129343
Study groupRoleWhat they receive
All Participants With VWDExperimentalParticipants will receive a single intravenous (IV) dose of VONVENDI at baseline PK assessment. During the 12-month on-demand (OD) treatment period, any bleeding episodes requiring replacement therapy with VWF will be treated with VONVENDI with or without ADVATE. Participants may also receive VONVENDI with or without ADVATE intravenous infusions, when indicated deemed necessary for perioperative bleeding management [major, minor and oral surgery]. Participants will receive initial dose of VONVENDI of 40 to 80 IU/kg of body weight.
Receives: Biological: VONVENDI; Biological: ADVATE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.

    Measured: Up to 14 months

  2. Number of Participants With TEAEs by Severity

    Number of participants with severity of TEAE will be reported.

    Measured: Up to 14 months

  3. Number of Participants With TEAEs and SAEs by Causality

    Number of participants with causality related TEAEs and SAEs will be reported.

    Measured: Up to 14 months

  4. Number of Participants With Thromboembolic Events and Severe Hypersensitivity Reactions

    Number of participants with thromboembolic events and severe hypersensitivity reactions will be reported.

    Measured: Up to 14 months

  5. Number of Participants Who Develop Neutralizing (Inhibitory) Antibodies to VWF and FVIII

    Number of participants who develop neutralizing antibodies to VWF and FVIII will be reported.

    Measured: Up to 14 months

  6. Number of Participants Who Develop Binding Antibodies to VWF and FVIII

    Number of participants who develop total binding antibodies to VWF and FVIII will be reported.

    Measured: Up to 14 months

  7. Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

    Number of participants with clinically significant abnormalities from baseline values in laboratory parameters per investigator assessment will be reported.

    Measured: Up to 14 months

  8. Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)

    Number of participants with clinically significant abnormalities from baseline values in ECG per investigator assessment will be reported.

    Measured: Up to 14 months

  9. Number of Participants With Clinically Significant Abnormalities in Vital Signs Parameters

    Number of participants with clinically significant abnormalities from baseline values in vital sign parameters per investigator assessment will be reported.

    Measured: Up to 14 months

Secondary outcomes (31)

  1. Number of Infusions of VONVENDI With or Without ADVATE per Bleeding Episode

    Number of infusions of VONVENDI with or without ADVATE per bleeding episode will be reported.

    Measured: Up to 12 months

  2. Number of Infusions of ADVATE per Bleeding Episode

    Number of infusions of ADVATE per bleeding episode will be reported.

    Measured: Up to 12 months

  3. Weight-adjusted Consumption of VONVENDI and ADVATE per Bleeding Episode

    Weight-adjusted consumption of VONVENDI and ADVATE per bleeding episode will be reported.

    Measured: Up to 12 months

  4. Time to Resolution of Bleeding Episodes

    Time to resolution of the bleeding episodes will be calculated as the difference between the date/time of the first IP infusion for the bleeding episode to the date/time of the bleeding episode resolution.

    Measured: Up to 12 months

  5. Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-inf) for VWF: Ristocetin Cofactor (VWF:Rco), VWF: Antigen (VWF:Ag) and VWF: Collagen Binding Capacity (VWF:CB)

    AUC0-inf parameter at the baseline PK assessment will be calculated using noncompartmental analysis (NCA) for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  6. Dose Normalized AUC (0-inf) for VWF:RCo, VWF:Ag and VWF:CB

    Dose normalized AUC0-inf parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  7. AUC From Time 0 to 96 Hours (AUC0-96h) for VWF:RCo, VWF:Ag and VWF:CB

    AUC0-96h parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  8. Dose Normalized AUC(0-96h) for VWF:RCo, VWF:Ag and VWF:CB

    Dose normalized AUC0-96h parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  9. Maximum Plasma Concentration (Cmax) for VWF:RCo, VWF:Ag and VWF:CB

    Cmax parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  10. Dose Normalized Cmax for VWF:RCo, VWF:Ag and VWF:CB

    Dose normalized Cmax parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  11. Time to Reach Maximum Plasma Concentration (Tmax) for VWF:RCo, VWF:Ag and VWF:CB

    Tmax parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  12. Mean Residence Time for VWF:RCo, VWF:Ag and VWF:CB

    Mean residence time parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  13. Clearance for VWF:RCo, VWF:Ag and VWF:CB

    Clearance parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  14. Terminal Half-life (T1/2) for VWF:RCo, VWF:Ag and VWF:CB

    T1/2 parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  15. Volume of Distribution at Steady State (Vss) for VWF:RCo, VWF:Ag and VWF:CB

    Vss parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo, VWF:Ag, and VWF:CB.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  16. Incremental Recovery (IR) at Cmax for VWF:RCo and VWF:Ag

    IR parameter at the baseline PK assessment will be calculated using NCA for VWF:RCo and VWF:Ag.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  17. AUC From Time 0 to Last time of Measurable Activity (AUC0-tlast) for Factor VIII:Coagulation Activity (FVIII:C)

    AUC0-tlast parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  18. Dose Normalized AUC0-tlast for FVIII:C

    Dose Normalized AUC0-tlast parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  19. AUC0-96h for FVIII:C

    AUC0-96h parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  20. Dose Normalized AUC0-96h for FVIII:C

    Dose normalized AUC0-96h parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  21. Cmax for FVIII:C

    Cmax parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  22. Dose Normalized Cmax for FVIII:C

    Dose Normalized Cmax parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  23. Tmax for FVIII:C

    Tmax parameter at the baseline PK assessment will be calculated using NCA for FVIII: C.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  24. Plasma Level of VONVENDI based on Von Willebrand Factor: Ristocetin Cofactor (VWF:Rco)

    Plasma level of VONVENDI based on VWF:Rco will be reported.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  25. Plasma Level of VONVENDI based on Von Willebrand Factor Antigen (VWF:Ag)

    Plasma level of VONVENDI based on VWF:Ag will be reported.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  26. Plasma Level of VONVENDI based on Von Willebrand Factor Collagen Binding (VWF:CB)

    Plasma level of VONVENDI based on VWF:CB will be reported.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  27. Plasma Level of Factor VIII Clotting (FVIII:C)

    Plasma level of FVIII:C will be reported.

    Measured: At baseline: Within 1 hour pre-infusion, 0.25, 0.50, 1, 3, 6, 12, 24, 30, 48, 72, and 96 hours post-infusion

  28. Total Hemostatic Efficacy Assessment 24 hours After Last Perioperative IP Infusion or at Day 14 Postoperative Visit

    The overall hemostatic efficacy of VONVENDI, with or without ADVATE, will be assessed by the investigator using the hemostatic efficacy assessment rating scale either 24 hours after the last perioperative infusion or at the Day 14 postoperative visit, whichever comes first.

    Measured: At 24 hours or Day 14

  29. Total Volume of Actual and Predicted Intraoperative Blood Loss After the Surgery as Assessed by the Operating Surgeon

    Intraoperative actual blood loss will be assessed by the operating surgeon at the completion of surgery using a predefined 4-point rating scale. 1- Excellent (intraoperative blood loss was less than or equal to the maximum expected for the type of procedure performed in a hemostatically normal individual [<=]100 percent [%]); 2- Good (intraoperative blood loss up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal individual [101%-150%]); 3- Moderate (intraoperative blood loss exceeding 50% of the expected for the type of procedure performed in a hemostatically normal individual [greater than (>)150%]); 4- None (uncontrolled hemorrhage due to an inadequate therapeutic response despite appropriate dosing, necessitating a change of clotting factor replacement regimen). Lower scores indicate better hemostatic efficacy. Scoring is calculated by comparing the actual blood loss versus predicted blood loss.

    Measured: From Intraoperative through completion of surgery (up to Day 14)

  30. Intraoperative Hemostatic Efficacy Score as Assessed by Operating Surgeon at Completion of Surgery

    The hemostasis assessment rating scale ranges from 1 to 4, where 1 = Excellent, 2 = Good, 3 = Moderate, and 4 = None. Lower scores indicate better hemostatic efficacy.

    Measured: At completion of surgery (up to Day 14)

  31. Daily Intra- and Postoperative Weight-adjusted Dose of VONVENDI With or Without ADVATE Through Postoperative Day 14

    Daily intra- and postoperative weight-adjusted dose of VONVENDI with or without ADVATE through postoperative day 14 will be reported.

    Measured: From day of surgery through postoperative Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start13 Oct 2025
  3. Primary completion25 Nov 2027 (estimated)
  4. Study completion25 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07129343
Sponsor's protocol ID
TAK-577-3002
Status last verified
Jan 2026
First submitted
12 Aug 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VONVENDI and ADVATE in people with Von Willebrand Disease (VWD), run by Takeda at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 14 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07129343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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